A Study of an Experimental COVID-19 Vaccine by Novavax in Pediatrics Age 12-17, Sponsored by NIAID
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"Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 12 to 17
Gender:
Any
Healthy Volunteers: Yes
Keywords: Covid-19, Covid, Vaccine, Covid-19 Vaccine, Covid Vaccine
Type: Drug study, Phase 1/2
Investigator:
Description
This is a Phase III trial, aiming to assess the efficacy of the NOVAVAX SARS-CoV-2 Nanoparticle Vaccine with Matrix M-1 in preventing COVID-19 disease. This vaccine is NOT made using infectious virus, so it cannot give you COVID-19. This vaccine is not yet approved for Emergency Use in the United States, and is still being reviewed by the FDA. The vaccine is currently being studied in an Adult Phase III trial with approximately 30,000 participants and has currently been shown to be well-tolerated.
This study requires

This study will require 11-12 in person visits at the University of California, Davis Medical Center. At these visits, the study team will thoroughly explain the study, all procedures and tests, and can answer any questions. If both the child and their guardian consent to participation, we will first assess the child's health (by performing a physical exam, gathering their vital signs, and if applicable running a pregnancy test), we will also gather a blood sample, and administer the Investigational Product (vaccine or placebo), and observe them for safety for 30 minutes. Some visits may not require all of these procedures, but this can give you an idea of what is to be expected at the visits.

The study will also require the guardians to stay in contact with the study team via frequent phone calls or emails, and assuring the participant's completion of a daily "Symptom Survey" which is available through an app on your mobile device.

Who can participate

You can join the study if you (or your child) are:

  • 12 to 17 years old
  • Child participant willing to assent to participation in trial
  • Physically Healthy (well controlled HIV is approved)
  • Have not been diagnosed with COVID-19 in the past
  • Not participating in any other COVID-19 research trials
  • Are not prescribed immunosuppressant or corticosteroid medication
Benefits and risks of participating
All medicines, including vaccines, can have some risks or cause certain side effects and discomforts, although not everybody experiences them. Side effects are any unwanted or sometimes unpleasant reactions that may happen after getting injections.

The known risks, side effects, and discomfort when people receive any vaccine are injection site reactions, which result in redness, itching, or a painful sensation at the place of the injection.
Compensation
Visits will be compensated
Resources
Schedule
Study duration and period
2 years
Location
UC Davis Medical Center
2221 Stockton Boulevard
Sacramento, CA 95817
Contact
Novavax Study Team
Research Topic
Conditions:
  • COVID-19
  • healthy participants

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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